Safety and Tolerability of Aripiprazole in Adolescents With Schizophrenia or Children and Adolescents With Bipolar I Disorder, Manic or Mixed Episode With or Without Psychotic Features.

NCT ID: NCT01122927

Last Updated: 2016-02-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 524 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2014-09-30

Brief Summary

This is an open-label study consisting of a screening period, a conversion/titration phase (Phase 1), an open-label treatment phase (Phase 2), and a follow-up period.

The study will enroll new subjects (hereafter referred as "de novo" subjects) with schizophrenia, or bipolar I disorder, manic or mixed episode with or without psychotic features, and rollover subjects with schizophrenia from 31-09-266 (hereafter referred to as "Study 266"). All de novo subjects must enter the screening period of the study. Subjects who are screened and are not required to go through Phase 1 will complete a Phase 2 baseline visit prior to their participation in Phase 2.

Study Design: Treatment, Single Group Assignment, Open Label, Active Control, Safety/Efficacy Study

Conditions

Adolescent Schizophrenia; Child or Adolescent Bipolar I Disorder, Manic or Mixed Episode With or Without Psychotic Features

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Phase 1 and Phase 2

Aripiprazole (2-mg, 5-mg, 10-mg, 15-mg, 20-mg, 25-mg or 30-mg)

Group Type: EXPERIMENTAL

Aripiprazole

Intervention Type: DRUG

Aripiprazole (2-mg, 5-mg, 10-mg, 15-mg, 20-mg, 25-mg or 30-mg) pill taken orally once per day

Interventions

Aripiprazole

Aripiprazole (2-mg, 5-mg, 10-mg, 15-mg, 20-mg, 25-mg or 30-mg) pill taken orally once per day

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Subjects 13-17 years old (Schizophrenia); Subjects 10-17 years old (Bipolar manic or mixed episode)* [*Bulgaria will enroll Schizophrenia subjects only.]
• Subjects with a current diagnosis of schizophrenia, and a history of the illness (diagnosis or symptoms) for at least 6 months prior to screening (as per subject, family, or healthcare provider, or by previous medical records).
• Subjects with a current diagnosis of bipolar I disorder, manic or mixed episode with or without psychotic features (diagnosis or symptoms) experiencing symptoms for at least 1 week prior to screening. * [*These subjects will not be eligible to enroll in Bulgaria]
• Subjects who have shown previous response to antipsychotic treatment (other than clozapine) and are not resistant to treatment with other antipsychotics.
• Subjects who are currently being treated with oral antipsychotics other than clozapine, and are not resistant to treatment with other antipsychotics.
• Inpatient or outpatient status, with the exception of acute hospitalization due to psychiatric reasons at the time of screening or before Phase 2.

Exclusion Criteria

• All subjects: diagnosis of schizoaffective disorder, autism, pervasive developmental disorder (PDD), OCD, or PTSD.
• Subjects with schizophrenia: a current major depressive episode.
• Subjects with bipolar manic or mixed episode: presenting with a clinical picture and/or history that is consistent with a diagnosis of bipolar II disorder or bipolar disorder not otherwise specified.
• Subjects with delirium, dementia, amnesia or other cognitive disorders; subjects with psychotic symptoms that are better accounted for by another general medical condition(s) or direct effect of a substance (i.e., medication, illicit drug use, etc.).
• Subjects with any neurological disorder, with the exception of Tourette's syndrome.
• Subjects experiencing major depressive episode at the time of screening other than subjects diagnosed with bipolar I disorder mixed episode.
• Subjects who are currently receiving clozapine or have received clozapine at any time in the past are ineligible for entry into the study.
• Subjects who meet the DSM-IV-TR criteria for substance dependence (including alcohol and benzodiazepines, but excluding caffeine and nicotine) within the past 180 days prior to screening.
• Subjects who have epilepsy, a history of seizures (except for a single childhood febrile seizure or post-traumatic seizure), or a history of severe head trauma or stroke, or have a history or current evidence of other unstable medical conditions.
• Subjects with a history of subclinical hypothyroidism (TSH ≥ 4.0 mIU/L), known hypothyroidism, or hyperthyroidism (unless the condition has been stabilized with medications for at least 90 days prior to entry into Phase 1 or Phase 2).
• Subjects who have a medical history of uncontrolled diabetes, labile or unstable diabetes (brittle diabetes), newly diagnosed diabetes, or clinically significant abnormal blood glucose levels (defined as fasting blood glucose ≥ 125 mg/dL).

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Otsuka Pharmaceutical Development & Commercialization, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eva Kohegyi, MD

Role: STUDY_DIRECTOR

Otsuka Pharmaceutical Development and Commercialization, Inc.

Locations

Study Site

Dothan, Alabama, United States

Study Site

Downey, California, United States

Study Site

Miami, Florida, United States

Study Site

Miami, Florida, United States

Study Site

Atlanta, Georgia, United States

Study Site

Smyrna, Georgia, United States

Study Site

Oak Brook, Illinois, United States

Study Site

Wichita, Kansas, United States

Study Site

Minneapolis, Minnesota, United States

Study Site

Buffalo, New York, United States

Study Site

Stony Brook, New York, United States

Study Site

Chapel Hill, North Carolina, United States

Study Site

Cincinnati, Ohio, United States

Study Site

Cleveland, Ohio, United States

Study Site

Oklahoma City, Oklahoma, United States

Study Site

Philadelphia, Pennsylvania, United States

Study Site

Houston, Texas, United States

Study Site

San Antonio, Texas, United States

Study Site

The Woodlands, Texas, United States

Study Site

Richmond, Virginia, United States

Study Site

Bellevue, Washington, United States

Study Site

Bothell, Washington, United States

Study Site

Milwaukee, Wisconsin, United States

Study Site

Burgas, , Bulgaria

Study Site

Pazardzhik, , Bulgaria

Study Site

Plovdiv, , Bulgaria

Study Site

Rousse, , Bulgaria

Study Site 2

Sofia, , Bulgaria

Study Site

Targovishte, , Bulgaria

Study Site 1

Varna, , Bulgaria

Study Site 2

Varna, , Bulgaria

Study Site

Rijeka, , Croatia

Study Site 1

Zagreb, , Croatia

Study Site 2

Zagreb, , Croatia

Study Site

Budapest, , Hungary

Study Site

Budapest, , Hungary

Study Site

Gyula, , Hungary

Study Site

Szeged, , Hungary

Study Site

Vijayawada, Andhra Pradesh, India

Study Site

Visakhapatnam, Andhra Pradesh, India

Study Site

Visakhapatnam, Andhra Pradesh, India

Study Site 1

Ahmedabad, Gujarat, India

Study Site 2

Ahmedabad, Gujarat, India

Study Site

Ahmedabad, Gujarat, India

Study Site

Maninagar, Ahmedabad, Gujarat, India

Study Site

Mangalore, Karnataka, India

Study Site

Calicut, Kerala, India

Study Site

Nashik, Maharashtra, India

Study Site

Ludhiana, Punjab, India

Study Site

Jaipur, Rajasthan, India

Study Site

Chennai, Tamil Nadu, India

Study Site

Maduri, Tamil Nadu, India

Study Site

Kanpur, Uttar Pradesh, India

Study Site

Lucknow, Uttar Pradesh, India

Study Site

Varanasi, Uttar Pradesh, India

Study Site

Guntur, , India

Study Site

Kuala Lumpur, Kuala Lumpur, Malaysia

Study Site

Dasmariñas, Cavite, Philippines

Study Site

Manila, National Capital Region, Philippines

Study Site

Iloilo City, , Philippines

Study Site

Mandaluyong, , Philippines

Study Site

Bialystok, , Poland

Study Site

Gdansk Wrzeszcz, , Poland

Study Site

Torun, , Poland

Study Site

Wroclaw, , Poland

Study Site

Wroclaw, , Poland

Study Site

Cluj-Napoca, Cluj, Romania

Study Site

Timișoara, Timiș County, Romania

Study Site

Bucharest, , Romania

Study Site

Craiova, Dolj, , Romania

Study Site

Iași, , Romania

Study Site

Nizhny Novgorod, Russian Federation, Russia

Study Site

Novosibirsk, Russian Federation, Russia

Study Site

Tonnelnyi Township, Russian Federation, Russia

Study Site

Kazan', , Russia

Study Site

Lipetsk, , Russia

Study Site

Moscow, , Russia

Study Site

Moscow, , Russia

Study Site

Orenburg Region, , Russia

Study Site

Petrozavodsk, , Russia

Study Site

Saint Petersburg, , Russia

Study Site

Saint Petersburg, , Russia

Study Site

Saratov, , Russia

Study Site

Tomsk, , Russia

Study Site

Yaroslavl, , Russia

Study Site

Yekaterinburg, , Russia

Study Site 1

Belgrade, , Serbia

Study Site 2

Belgrade, , Serbia

Study Site

Novi Sad, , Serbia

Study Site

Taipei, , Taiwan

Study Site

Dnipro, , Ukraine

Study Site

Donetsk, , Ukraine

Study Site 1

Kharkiv, , Ukraine

Study Site 2

Kharkiv, , Ukraine

Study Site

Kherson, , Ukraine

Study Site

Luhansk, , Ukraine

Study Site

Lviv, , Ukraine

Study Site

Odesa, , Ukraine

Study Site

Simferopol Crimea, , Ukraine

Study Site

Temopil, , Ukraine

Study Site

Vinnytsia, , Ukraine

Countries

United States; Bulgaria; Croatia; Hungary; India; Malaysia; Philippines; Poland; Romania; Russia; Serbia; Taiwan; Ukraine

Other Identifiers

31-09-267

Identifier Type: -

Identifier Source: org_study_id